1.1 This test method covers the materials and methods for the fatigue testing of spinal implant assemblies in a cadaveric model. 1.2 This test method is intended to provide a basis for the mechanical comparison of the bone-implant interface among past, present, and future spinal assemblies. This method is not intended to define level of performance since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 This test method is not intended as an evaluation of the mechanical properties of the implant in isolation, but rather, it is intended to evaluate the loss of intervertebral fixation in a cadaveric fatigue model. 1.4 This test method is not intended to supplant any of the existing test standards pertaining to the mechanical properties of spinal implants (F1717, F0277 etc.). It is rather intended to provide additional information regarding the stability of the bone-implant interface, as measured through loss of fixation, only after the structural stability of implant components has been sufficiently established through the use of said tests. 1.5 The test method describes dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of spinal implants that employ some form of bone anchoring technology. 1.6 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Currently, no cadaveric bone implant interface test methods exist.
Keywordsspine implants; cadaveric; dynamic test methods; fatigue; bone implant interface; pure moment
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development